Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillators

Larry W. Minor
Federal Motor Carrier Safety Administration
October 26, 2015

[Federal Register Volume 80, Number 206 (Monday, October 26, 2015)]
[Notices]
[Pages 65285-65286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27210]


-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration


Docket No. FMCSA-2012-0081]

Qualification of Drivers; Exemption Applications; Implantable 
Cardioverter Defibrillators

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of denials of exemption applications.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces its decision to deny applications from 14 of 
15 individuals seeking exemptions from the Federal cardiovascular 
standard applicable to interstate truck and bus drivers and the reasons 
for the denials. The Agency reviewed the medical information of each of 
the individuals who applied for an implantable cardioverter 
defibrillator (ICD) exemption. Because the medical information received 
from the cardiologist concerning one individual indicates the ICD has 
been disabled due to improvement of his heart function, the exemption 
is no longer needed to operate commercial motor vehicles (CMVs) in 
interstate commerce. Based on a review of the applications and 
following an opportunity for public comment, FMCSA has concluded that 
the remaining 14 individuals in the notice did not demonstrate they 
could achieve a level of safety that is equivalent to, or greater than, 
the level of safety that would be obtained by complying with the 
regulation.

DATES: Denial letters were sent to each of the individuals listed in 
this notice on July 24, 2015.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief Medical 
Programs Division, 202-366-4001, U.S. Department of Transportation, 
FMCSA, 1200 New Jersey Avenue SE., Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through Friday, 
except Federal holidays.

SUPPLEMENTARY INFORMATION: 

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption 
from the Federal Motor Carrier Safety Regulations for a 2-year period 
if it finds ``such exemption would likely achieve a level of safety 
that is equivalent to or greater than the level that would be achieved 
absent such exemption.'' FMCSA can renew exemptions at the end of each 
2-year period.
    On April 21, 2015, FMCSA published for public notice and comment, 
FMCSA 2012-0081 listing 15 individuals seeking exemptions for ICDs. 
Accordingly, the Agency has evaluated each applicant's request to 
determine whether granting an exemption will achieve the required level 
of safety mandated by statute.

Evaluation Criteria--Cardiovascular Medical Standard and Advisory 
Criteria

    The individuals included in this notice have requested an exemption 
from the provisions of 49 CFR 391.41(b)(4), which applies to drivers 
who operate CMVs in interstate commerce, as defined in 49 CFR 390.5. 
Section 391.41(b)(4) states that:

``. . . a person is physically qualified to drive a commercial motor 
vehicle if that person has no current clinical diagnosis of 
myocardial infarction, angina pectoris, coronary insufficiency, 
thrombosis, or any other cardiovascular disease of a variety known 
to be accompanied by syncope (temporary loss of consciousness due to 
a sudden decline in blood flow to the brain), dyspnea (shortness of 
breath), collapse, or congestive cardiac failure.''

    The FMCSA provides medical advisory criteria as recommendations for 
use by medical examiners in determining whether drivers with certain 
medical conditions, procedures, and/or treatments should be certified 
to operate CMVs in interstate commerce in accordance with the various 
physical qualification standards in 49 CFR part 391, subpart E. The 
advisory criteria are currently set out as part of the medical 
examination report published with 49 CFR 391.43. The advisory criteria 
for section 391.41(b)(4) provide that:

    The term ``has no current clinical diagnosis of'' is 
specifically designed to encompass: ``a clinical diagnosis of'' (1) 
a current cardiovascular condition, or (2) a cardiovascular 
condition which has not fully stabilized regardless of the time 
limit. The term ``known to be accompanied by'' is designed to 
include a clinical diagnosis of a cardiovascular disease (1) which 
is accompanied by symptoms of syncope, dyspnea, collapse or 
congestive cardiac failure; and/or (2) which is likely to cause

[[Page 65286]]

syncope, dyspnea, collapse, or congestive cardiac failure.
    It is the intent of the FMCSRs to render unqualified, a driver 
who has a current cardiovascular disease which is accompanied by 
and/or likely to cause symptoms of syncope, dyspnea, collapse, or 
congestive cardiac failure. However, the subjective decision of 
whether the nature and severity of an individual's condition will 
likely cause symptoms of cardiovascular insufficiency is on an 
individual basis and qualification rests with the medical examiner 
and the motor carrier.

    In the case of persons with ICDs, the underlying condition for 
which the ICD was implanted places the individual at high risk for 
syncope (a transient loss of consciousness) or other unpredictable 
events known to result in gradual or sudden incapacitation. ICDs may 
discharge, which could result in loss of ability to safely control a 
CMV. See the Evidence Report on Cardiovascular Disease and Commercial 
Motor vehicle Driver Safety, April 2007.\1\ A focused research report 
on Implantable Cardioverter Defibrillators and the Impact of a Shock on 
a Patient When Deployed completed for the FMCSA December 2014 indicates 
that the available scientific data on persons with ICDs and CMV driving 
does not support that persons with ICDs who operate CMVs are able to 
meet an equal or greater level of safety and upholds the findings of 
the April 2007 report.
---------------------------------------------------------------------------

    \1\ Now available at http://ntl.bts.gov/lib/30000/30100/30123/Final_CVD_Evidence_Report_v2.pdf.
---------------------------------------------------------------------------

Discussion of Public Comments

    On April 21, 2015, FMCSA published in a Federal Register Notice, 
the names of 15 individuals requesting ICD exemption and requested 
public comment. The public comment period closed on May 21, 2015. A 
total of 29 commenters responded to the notice. The majority of 
commenters were in favor of the applicants continuing to drive CMV's 
with ICD's. Commenters believed that the individuals seeking exemptions 
were responsible drivers who had safe driving histories and were 
compliant with their medical treatment programs. One anonymous 
commenter encouraged the FMCSA not to grant these individuals 
exemptions due to concerns of the risks of the underlying medical 
conditions in combination with operating a commercial motor vehicle.

FMCSA's Response

    FMCSA acknowledges the commenters' reports of medical compliance 
and safe driving histories of the applicants. However, based on the 
available medical literature and data, FMCSA believes that drivers with 
an ICD are at risk for incapacitation if the device discharges in 
response to cardiovascular symptoms. This risk is combined with the 
risks associated with the underlying cardiovascular condition for which 
the ICD has been implanted as a primary or secondary preventive 
measure.
    Mr. Leslie Mitchell no longer has a functioning ICD and may operate 
CMVs in interstate commerce based on the decision of the medical 
examiner. Mr. Mitchell has a pacemaker/ICD but the ICD portion was 
disabled because his cardiologist determined he no longer needs 
tachycardia therapy. Therefore, if a medical examiner determines that 
he meets the cardiovascular standard and all other physical 
qualification standards for operating a commercial motor vehicle in 
interstate commerce, he may be issued a medical certificate.

Conclusion

    FMCSA evaluated the remaining 14 of 15 individual exemption 
requests on their merits, available data from Evidence Reports and 
Medical Expert Panel opinions on ICDs and commercial motor vehicle 
driving, and the public comments received. The Agency has determined 
that the available medical literature and data does not support a 
conclusion that granting these exemptions would achieve a level of 
safety equivalent to or greater than, the level of safety maintained 
without the exemptions. Each applicant has, prior to this notice, 
received a letter of final disposition on his/her exemption request. 
Those decision letters fully outlined the basis for the denial and 
constitute final Agency action. The list published today summarizes the 
Agency's recent denials as required under 49 U.S.C. 31315(b)(4).
    The following 14 applicants are denied exemptions from the 
cardiovascular standard concerning ICDs.

Craig Bohms
James Dean
Terry Goodhile
David Allan Jensen
Michael Politz
Charles Rhodes
Mark Steiner
Daniel Donahue
Bernard Fritzson
Ronald Heinlein
Douglas Lopez
Mark Register
Stephen Watts
John Allen Weltz

    Issued on: October 15, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-27210 Filed 10-23-15; 8:45 am]
 BILLING CODE 4910-EX-P